• Biophan Technologies (Rochester, New York) reported that the U.S. Patent and Trademark Office recently issued the company two new patents. The patents are for methods of signaling the heart, which improve the function of implanted cardiovascular devices. The first, U.S. patent No. 7,020,517, teaches a means of detecting and responding in a manner that avoids the onset of ventricular fibrillation. The method uses a low voltage electrical signal, which can be built into a low cost pacemaker and provide some protection against fibrillation events. The technology can also be deployed in a cardio-defibrillator as a means of controlling fibrillation to avoid the need for the 800-volt charge traditionally used in implantable defibrillators. The second patent, U.S. patent No. 7,054,686, teaches use of a high-frequency pulse sequence in place of a single pacing signal so that stimulation of the heart can occur with lower energy, a technique with the potential to improve battery life of implantable devices.

• Cepheid (Sunnyvale, California), a broad-based molecular diagnostics company, reported the European release of the Smart VZV Assay for clinical diagnostic use on the SmartCycler System. The VZV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Smart VZV is intended for rapid detection of the varicella-zoster virus, a member of the herpes virus subfamily. Cepheid's Smart VZV delivers a positive or negative result in under an hour after DNA extraction.

• Clinical Data (Newton, Massachusetts), a provider of comprehensive molecular and pharmacogenomics services as well as genetic tests, reported that its PgxHealth division will provide a genetic test to clinicians that is associated with response to warfarin, a commonly prescribed drug to treat and prevent blood clots. The company has been granted commercialization rights relating to certain polymorphisms in the Vitamin K epoxide reductase complex gene (VKORC1). Polymorphisms within the VKORC1 gene are one of the important predictors of response to warfarin. The company said the genetic test for warfarin response should, when combined with certain clinical information, explain or predict more than 50% of the variability in response to warfarin. The company anticipates that PGxHealth will make this test commercially available by the end of the year.

• GE Healthcare (Waukesha, Wisconsin) said data from two recent studies comparing bone densitometers found that the GE Lunar Prodigy has lower precision error when measuring changes in bone mineral density (BMD). The Prodigy uses direct-digital technology that has been proven to have better precision for BMD testing in the detection of osteoporosis. The two studies were presented earlier this week at the International Osteoporosis Foundation World Congress on Osteoporosis in Toronto. In the first study, BMD was measured with the Lunar Prodigy and another system in 20 women aged 59 to 65 years. The authors found that precision at the femur, a critical fracture site, was significantly better with the Prodigy. In the second study, a total of 31 women aged 54 to 77 years were measured. This study concluded that BMD precision error with the Lunar Prodigy was significantly lower than the other system at both the femur and spine.

• Medrad (Indianola, Pennsylvania) received FDA clearance for use of its Continuum MR Infusion System in magnetic resonance (MR) environments up to and including 3.0 Tesla (T). The clearance enables clinicians working in the latest 3.0T environments to infuse medications, sedatives, and other drugs while benefiting from Continuum's ease-of-use and dose enhancements. In the most recent enhancement to Continuum, introduced in 2002 as the first MR compatible infusion system, Medrad added a greater selection of drug-specific units of measurement, increasing the number of drugs that can be infused. It also helps prevent programming errors by reducing the confusion of manual conversions.

• Nanomix (Emeryville, California), a nanoelectronic detection company commercializing diagnostic and monitoring applications, reported that it was issued U.S. patent No. 7,036,324. The new patent is related to hydrogen storage technology and follows five earlier patents issued to Nanomix in this field. The new technology avoids the current limitations of liquid hydrogen storage. The system employs a combination of thermal insulation and an enclosure for the storage and controlled distribution of hydrogen as a high-energy fuel. This can address storage life limitations, energy penalties, and/or weight penalties associated with liquid hydrogen, metallic hydride and high-pressure gas-phase hydrogen storage.

• Repligen (Waltham, Massachusetts), developing therapeutics for neuropsychiatric disorders and autoimmune disease, reported that the company has initiated a clinical trial to evaluate the use of RG1068, synthetic human secretin, as an agent to improve the detection of structural abnormalities of the pancreatic ducts during MRI imaging of the pancreas. In the multicenter, baseline controlled, single dose study, 80 patients with a history of pancreatitis will receive a secretin-enhanced MRI and an unenhanced MRI of the pancreas. The study will assess the sensitivity and specificity of secretin-enhanced MRI to improve the ability to detect pancreatic duct abnormalities relative to unenhanced MRI, as well as the safety of secretin in combination with MRI.

• Telzuit Medical Technologies (Orlando, Florida) reported that it has successfully tested a prototype of its wireless heart monitor using Bluetooth technology delivered by Cambridge Silicon Radio's (Cambridge, UK) BlueCore3. The integration of the Bluetooth component signifies the final step in the development of Telzuit's flagship 12-lead wireless heart monitor, readying the product for its initial production run and positioning it for formal launch in 2006. The completion of this prototype also clears the way for final development and implementation of the company's other mobile medical devices, including an FDA-approved 12-lead wireless cardiac event monitor; a home sleep apnea test; and a long-term care patient solution incorporating Telzuit's core wireless technology.

• Tomen America (New York) said a study in the current edition of Diabetes Care demonstrates that the new GlycoMark blood test is a better measure of after-meal or postprandial glucose levels compared to standard tests for diabetes. The company called it "a very important finding" as elevated after-meal glucose levels are associated with cardiovascular complications, the leading cause of death in patients with diabetes. The study shows that although the current gold standard diabetes test, hemoglobin A1C, may indicate adequate control of glucose levels, after-meal glucose levels may still be elevated. The GlycoMark test, which measures circulating levels of 1,5- anhydroglucitol (1,5-AG), a sugar similar to glucose, reflects after-meal glucose levels over the previous one to two weeks. The authors of the study conclude that, "1,5-AG was reflective of varying postmeal glucose levels, despite similarities in A1Cs. Thus, the 1,5-AG assay may facilitate achieving good glycemic control in patients with suboptimal A1Cs by identifying patients in whom postprandial glucose elevations predominate."

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